綠葉製藥(02186.HK)就旗下精神分裂症藥物向美國FDA提交新藥上市申請
綠葉製藥(02186.HK)公布,已向美國食品藥品監督管理局(FDA)提交棕櫚酸帕利(口派)酮緩釋混懸注射液「LY03010」的新藥上市申請(NDA),用於治療精神分裂症和分裂情感性障礙。
LY03010基於公司的長效及緩釋技術平台自主研發,有望成為首個在美國獲批、由中國企業生產的棕櫚酸帕利(口派)酮長效注射劑。目前LY03010在中國已處於上市評審階段。
帕利(口派)酮是治療精神分裂症的一線用藥之一,可緩解精神病陽性症狀,同時改善認知和情感症狀。帕利(口派)酮有口服片劑及長效注射針劑兩種劑型。在長期治療中更顯著地降低復發風險,改善患者長期獲益。
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